Abstract
IntroductionThe National Centre for Pharmacoeconomics (NCPE) assesses the cost-effectiveness of new drugs for which reimbursement by the healthcare payer, the Health Service Executive (HSE), is sought in Ireland. This research aims to create a systematic approach for the NCPE review group (RG) to assess each of the cost-effectiveness models submitted by the applicant by creating cost-effectiveness model appraisal guidelines.MethodsThe RG consists of clinical, statistical and health economic expertise. In order to systematically appraise the HTA submission, which includes a cost-effectiveness model, clear guidelines on how each of the members of the RG can work together are required. The current members of the RG in the NCPE were given a draft of the guidelines created by the primary author, and additional feedback and testing was performed using the expert experience of the team. A version of the guidelines was tested for its usefulness.ResultsThree checklists were created. The purpose of the first checklist is to evaluate if the cost-effectiveness model works correctly. The second checklist ensures that each of the assumptions included in the HTA dossier are the same as those included in the cost-effectiveness model. The final checklist validates the assumptions used in the cost-effectiveness model to ensure they are reasonable and appropriate for decision making. The final version of the checklists were validated by choosing cost-effectiveness models with known errors and/or discrepancies and testing that the issues were captured by the checklists.ConclusionsThese guidelines are not an exhaustive list of checks that should be performed, but are presented as the minimum requirements for consideration to be included with each RG assessment of the corresponding HTA submission. The guidelines will be constantly updated as the process evolves over time. The cost-effectiveness models should follow the National Health Information and Quality Authority (HIQA) Guidelines for the Economic Evaluation of Health Technologies in Ireland.
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